Performance Qualification of Vial Washing Machine|Challenge Test for Vial Washing Machine|PQ of Vial Washing Machine

Vial washing machine is the one of critical Equipment in the aseptic manufacturing process which plays a crucial role in preparing containers for aseptic filling. To meet regulatory requirements, it is essential to conduct a thorough qualification of the vial washing machine. This article aims to provide a comprehensive guide for the qualification vial washing machine, covering all key concepts, processes, and regulatory considerations.

Understanding Vial Washing Machine Principle:

Vial Washing Machine are two type liner and rotatory type. In both type the vials are cleaned in below mentioned Steps:-

1^st Step: External/Internal Wash with recirculated water

2^nd Step: External/Internal Compressed Air Blow

3^rd Step: Internal Wash with Purified water

4^th Step: External/Internal Compressed Air Blow

5^th Step External/Internal wash with Water for injection

6^th Step External/Internal Compressed Air Blow

Performance Qualification (PQ) and Requalification:

Performance of the vial washing machine evaluated in simulated production environment.

Challenge Test Planned for Vial Washing Machine

1.0  Spiked Vial with Riboflavin dye challenge for Proper cleaning and florescence observed after cleaning under the UV cabinet. Use can use the concentration between 0.08g/L to 0.22g/L

2.0  Spiked Vials with Charcoal Slurry for determination of Visible and sub visible black particle after washing of vial. Vials Challenged in the white background for Visible Particles and for sub visible analysed through Liquid Born particle analyser.

3.0   Spiked Vials with Talcum powder for determination of Visible and sub visible white particle after washing of vial. Vials Challenged in the black background for Visible Particles and for sub visible analysed through Liquid Born particle analyser.

4.0  Spiked Vials with glass particles for determination of Visible glass particle after washing of vial. Vials Challenged in the black and white background for Visible glass Particles

5.0  Spiked Vials with NaCl Solution for determination of chemical contamination after washing of vial. Cleaned Vials are test in QC for any NaCl residue contamination.

6.0  Residual water content after blowing of compressed air inside and outside of vial to assure the vial having less than 0.4g so that it will evaporate during dehydrogenation tunnel

7.0  Endotoxin Spiked vial challenge for 1 log reduction after washing.

Before Starting the challenge test 100 ml Sample for liquid born particle count analysis shall be collected for Recirculated Water, Purified Water, WFI purge with Compressed Air.